The Pharmaceutical Industry at a Glance Trends in cancer medical technology based on NDB open data

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Shinji Tsubakihara, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute

SUMMARY

1. Introduction

Medical technology is evolving at an ever-increasing pace, and the speed of this evolution is accelerating every year. In pharmaceuticals, the discovery of new responsible molecules and genetic abnormalities has spurred the development of modalities designed to act specifically on the responsible molecules. In surgery, minimally invasive procedures have been further expanded with the introduction of robot-assisted surgery, and in radiotherapy, heavy particle therapy and proton beam therapy have been developed to efficiently kill cancer cells with minimal impact on healthy cells. In the area of testing, the number of genetic tests that are covered by insurance has increased, and especially in the diagnosis of malignant tumors, there has been an evolution from companion diagnostics that look at individual gene mutations and use them as indicators for selecting tumor drugs to technologies that guide optimal treatment strategies through comprehensive searches for gene mutations, such as cancer genome profiling tests.

While these advances in medical technology bring good news to patients, the implementation of innovative innovations in clinical care inevitably increases development costs, leading to the current debate on the increase in medical costs. In most cases, new medical technologies are approved by the Ministry of Health, Labour and Welfare after proving their outcomes in clinical trials, such as survival, progression control, and QOL improvement, and are then discussed by academic societies in various fields before gaining universality as the standard treatment. However, in the current era of increasing medical costs, it is necessary to establish a system for backward-looking, bird's-eye view, and continuous analysis and evaluation using accumulated medical data to see if the various medical technologies developed and disseminated in clinical practice have improved patient outcomes, improved the quality of life of patients, enhanced the efficiency of medical care, and contributed to the sustainability of society.

In this survey, we used various open data available on the websites of public institutions on patient outcomes and medical technology over time. Although it is naturally impossible to statistically analyze the relationship between patient outcomes and the quality and quantity of various medical technologies using only information from these open data, we thought it would be possible to outline the relationship between each medical technology and changes in patient outcomes over a certain period of time.

The target diseases were defined as malignant oncologic diseases (cancer). The oncology area was determined to have more open data than other disease areas because oncology drug use, cancer medical technology receipts, and cancer test receipts can be quantitatively aggregated from NDB open data, and patient outcomes can be quantitatively aggregated from cancer mortality rates.

For cancer epidemiology, the Foundation for Cancer Research publishes a large amount of data annually as "Cancer Statistics " ¹⁾. Cancer Statistics" and "Latest Cancer Statistics" published by the National Cancer ^Center2) are valuable data platforms that provide a wealth of data on the prognosis of cancer patients. In this study, "cancer incidence rate" and "cancer mortality rate" were obtained from the platform of the National Cancer Center Cancer Information Service, and the amount of oncology drug prescriptions and the number of receipts for various cancer treatment technologies were obtained ^{from the} NDB Open ^Data3) of the Ministry of Health, Labour and Welfare, by data year (degree), The data were re-sorted into four groups: "children" aged 0-14, "AYA" (Adolescent & Young Adult) aged 15-39, "adults" aged 40-64, and "elderly" aged 65-89, and the trends were analyzed by gender.

Survey Methodology

Cancer incidence rates for 2016-2020 ^{from the} "National Cancer Incidence Data " ⁴ and cancer mortality rates for 2015-2022 ^{from the} "New Reference Population: National Cancer Mortality Data " ⁵ open data on the National Cancer Center website were calculated by dividing the aforementioned four age groups into male and female groups, and by dividing them into three categories: all cancers except epithelial cancer, blood cancer, and solid cancer, Solid cancers were tabulated in three categories: all cancers excluding epithelial cancers, blood cancers, and solid cancers. Blood cancers were defined as "malignant lymphoma," "multiple myeloma," and "leukemia," which were included in the original data, and solid cancers were defined as "oral and oropharyngeal cancer," "multiple myeloma," and "leukemia. Solid cancers were "oral cavity/pharynx," "esophagus," "stomach," "colon," "liver," "liver," and "colorectal, Liver, gallbladder/bile duct, pancreas, and larynx, Lungs, skin, prostate, bladder, kidneys, urinary tract (excluding bladder) urinary tract (excluding bladder)," "uterus," "breast," "ovary," "brain and central nervous system and "thyroid gland.

Medical technologies used in cancer care were tabulated by gender for the four aforementioned age groups using the NDB Open Data, 2nd (FY 2015) to 9th (FY 2022). The number of prescription units of "oncology drugs" was calculated from "Internal_Outpatient (Outpatient) _Quantity by sex and age," "Internal_Outpatient (Inpatient) _Quantity by sex and age," "Inpatient_Quantity by sex and age," and "Injection_Quantity by sex and age. The number of prescription units of "oncology drugs" was calculated from "Quantity by inpatient age group" and "Quantity by injectable_age group. In addition, "opium alkaloids," "synthetic narcotics," and "G-CSF preparations" for oral and topical use indicated for cancer pain as palliative and supportive care for cancer were also counted. "Synthetic narcotics" and "G-CSF preparations" were counted in the same way.

The number of medical practice receipts was calculated by adding "hematopoietic tumor cell antigen test" and "tumor marker test" to the tests classified as "malignant tumor tissue test" and "tumor marker" from "D test_number of calculations by sex and age". In addition to the tests classified as "malignant tumor tissue test" and "tumor marker," the "hematopoietic tumor cell antigen test," "hematopoietic tumor gene test," "Major BCR-ABL1," "immune-related gene reconstitution," and "UDP-glucosidase ", "UDP-glucuronyltransferase gene polymorphism", "Cytokeratin 19 mRNA", "WT1 mRNA ", "CCR4 protein", "FIP1L1-PDGFRα fusion gene test", "EGFR gene test (plasma) ", "Bone marrow micro residual disease measurement", "FLT3 gene test", "Bladder cancer related gene test", "JAK2 gene test", "BRCA1/2 gene test", "Cancer genome profiling test", " RAS gene test (plasma)", "Homologous recombination repair defect test", "Lung cancer-related gene multiple simultaneous test", "Malignant tumor gene test （The number of outpatient and inpatient receipts for "K surgery_calculated by sex and age" was tabulated. The number of outpatient and inpatient surgeries that included the term "malignant tumor" were counted from "K. Surgery_Calculations by sex and age. From "M Radiotherapy_Counts by sex and age," the number of outpatient and inpatient receipts were calculated, excluding "management fee" and "blood irradiation. The number of "hematopoietic stem cell transplants" is described later.

To check changes over time for data other than "HSCT," the annual percentage change (APC) of cancer incidence rates for 2016-2020 was calculated according to the method described in Reference ^{6) for} this five-year period. Other data extracted for the eight years from 2015 to 2022 were smoothed by calculating the APCs in five-year shifts and averaging them (hereafter, five-year shift APC average).

Results

(1) Trends in cancer incidence and mortality rates for each age group

First, we show the trends of cancer incidence rates and cancer mortality rates by sex for each age group, which were calculated for all cancers and those divided into blood cancers and solid cancers. Figure 1 shows the change in incidence rates per 100,000 population for the five-year period from 2016 to 2020, calculated using national cancer registry data. The National Cancer Registry data are published for 2016-2020 as of June 2024, which is a different time period from the cancer mortality rates and respective NDB data extracted for 2015-2022. The APCs of cancer incidence rates for the period under review are shown below: for all cancers in males, the 0-14 age group (hereafter referred to as "children") -0.8%, the 15-39 age group (hereafter referred to as "AYA") -1.5%, the 40-64 age group (hereafter referred to as "adults") -3.8%, the 65 The rate of change was negative in all age groups: -1.4% in the 15-39 age group (AYA group), -1.5% in the 40-64 age group (adult group), and -1.4% in the 65-89 age group (elderly group). For hematologic cancers, the rates were -0.4% in the pediatric group, -0.1% in the AYA group, -0.9% in the adult group, and 0.8% in the elderly group. For solid cancers, the rates were -3.1% in the pediatric group, -2.6% in the AYA group, -4.4% in the adult group, and -1.7% in the elderly group, indicating that solid cancers showed a greater annual decrease than blood cancers in all age groups among males.

The APCs for all-site cancer incidence in women were 1.3% in the pediatric group, -2.1% in the AYA group, -1.7% in the adult group, and -0.9% in the elderly group, with only the pediatric group showing a positive change. For hematologic cancers, the rates were 1.4% in the pediatric group, 0.4% in the AYA group, -1.9% in the adult group, and 1.1% in the elderly group. For solid cancers, the incidence rates were 2.5% in the pediatric group, -2.6% in the AYA group, -1.9% in the adult group, and -1.3% in the elderly group. As for the characteristics of the female incidence APC, only the adult group showed a decrease in hematologic cancers, and only the pediatric group showed an increase in solid cancers.

Next, the cancer mortality rates per 100,000 population by sex and cancer type (all cancers, hematologic cancers, and solid cancers) for each age group over the 8-year period from 2015 to 2022 are shown (Figure 2). (2.6%), adult group (-4.3%), and elderly group (-0.4%) for all cancer types. For hematologic cancers, the rates were -3.8% in the pediatric group, -3.9% in the AYA group, -3.7% in the adult group, and 1.2% in the elderly group. For solid cancer, the rates were -3.4% in the pediatric group, -2.6% in the AYA group, -4.4% in the adult group, and -0.5% in the elderly group. In men, a decrease in mortality was observed in all groups except the elderly, for both solid and blood cancers.

The 5-year moving APC averages of cancer mortality in women were -0.9% in the pediatric group, -3.2% in the AYA group, -1.5% in the adult group, and 0.1% in the elderly group for all sites. For blood cancers, the rates were -6.6% in the pediatric group, -5.7% in the AYA group, -3.5% in the adult group, and 1.0% in the elderly group. For solid cancer, the rates were 2.2% in the pediatric group, -3.1% in the AYA group, -1.6% in the adult group, and 0.0% in the elderly group.

As shown in Table 1, a decrease in cancer mortality was observed in many groups for both men and women during the period under review, but an increase in solid cancer mortality in girls was noteworthy.

(2) Trends in the amount of oncology drugs

Figure 3 shows the number of oral and injectable oncology drug units prescribed. The "New Drug Percentage" in the graph represents the percentage of units of "new molecular entities (NMEs)" launched in 2010 or later, using the total number of oncology units for each year as the denominator. The "bio ratio" represents the ratio of the number of units of bio-oncology drugs to the number of units of injectable oncology drugs for each fiscal year. Bio-oncology drugs include recombinant proteins, antibodies, antibody-drug conjugates (ADCs), and biosimilars.

In the pediatric group, the 5-year moving APC average of total oncology drug units from FY 2015 to FY 2022 was -0.2% for boys and -0.2% for girls; the proportion of new drugs, which had been around 2% of total oncology drug units until FY 2020, increased rapidly in FY 2021 for both sexes, with the 5-year moving APC average of 20.9% for boys and 21.7% for girls. indicated. In FY2022, bio-oncology drugs accounted for 1-2% of all injectable oncology drugs, but the 5-year moving APC average was 13.2% for boys and 6.3% for girls, indicating a similarly high rate of increase as for new drugs.

In the AYA group, the 5-year moving APC average of total oncology drug units was -0.3% for males and 0.4% for females; in FY2022, the proportion of new drugs reached 29.1% for males and 16.7% for females, approximately 2.5 times higher than in FY15 for both sexes, with the 5-year moving APC average being 14.7% for males and 19.7% for females The five-year moving APC average was 14.7% for males and 19.7% for females. The ratio of bio-oncology drugs has been increasing among males, accounting for approximately 10% of injectable oncology drugs in FY2022. The percentage of women did not change significantly and remained at over 20% (5-year moving APC average: 3.2% for men and 1.1% for women).

In the adult group, there was a marked increase in the number of oncology drug units among women, with a 5-year moving APC average of 3.7% (-0.5% for men). the percentage of new drugs in 2022 reached 25.5% for men and 13.5% for women, with a 5-year moving APC average of 19.3% for men and 29.6% for women. The proportion of bio-oncology drugs reached 26.4% for men and 30.6% for women in FY2022 (5-year mobile APC average: 5.1% for men and 2.0% for women).

In the elderly group, an increase in the number of oncology drug units was also observed in women, with a 5-year moving APC mean of 1.5% for men and 5.0% for women.The proportion of new drugs in 2022 was 30.9% for men and 16.8% for women, with a 5-year moving APC mean of 30.5% for men and 27.3% for women. The proportion of bio-oncology drugs for both men and women grew over time, reaching 28.9% for men and 29.8% for women in FY2022, with a 5-year moving APC average of 7.3% for men and 3.6% for women.

It is reported that women account for about 80% of cancer cases in the age group of 20 to 39 ^years7), and the favorable age group for breast and uterine cancer is concentrated in the age group of 40 to 60 ^years8), so it is inferred that the amount of tumor drugs used by women of AYA and adult generation is higher than that of men in the same age group. The same reason can be inferred for the difference in the number of receipts for malignant tumor surgery and radiotherapy between men and women shown below.

(3) Changes in cancer-specific tests

Figure 4 shows the number of receipts for cancer-specific tests. In the pediatric group, the number of cancer-specific test receipts increased over time for both males and females, with a 5-year moving APC average of 2.6% for boys and 3.9% for girls. 3.7%.

The number of receipts for specific tests in the AYA group was more than twice as high for females as for males. There was a decreasing trend over time for both sexes, with a 5-year moving APC average of -0.5% for males and -1.1% for females; in FY2022, the percentage of genetic testing was 5.8% for males and 2.4% for females, with a 5-year moving APC average of 8.6% for males and 14.0% for females.

The number of receipts in the adult group did not differ significantly between men and women, with a 5-year moving APC average of -0.5% for men and 0.1% for women; the percentage of genetic testing in FY2022 was similar for men (3.9%) and women (3.7%), and the 5-year moving APC average showed a high rate of increase (13.7% for men and 17.8% for women).

The elderly group was dominated by males, with a 5-year moving APC average of 0.2% for males and -0.4% for females.The percentage of genetic testing in FY2022 was similar to the adult group, at 3.8% for males and 3.6% for females, with a 5-year moving APC average of 16.5% for males and 17.2% for females, both with high rates of increase. The 5-year moving APC averages were 16.5% for males and 17.2% for females, both with high increase rates. These data indicate that in cancer-specific testing, the proportion of genetic testing is relatively high in younger age groups, and the rate of change in the proportion of genetic testing increases with older age. In the treatment of solid tumors such as lung cancer, which is common among the elderly, it was inferred that companion diagnoses to verify drug efficacy using gene panel ^tests9), etc., are increasing with the expansion of clinical use of new oncology drugs such as kinase inhibitors and antibodies that specifically affect cancers with certain genetic mutations.

(4) Trends in targeted surgeries for cancer

From the surgical receipt data in the NDB open data, the number of receipts for surgeries for malignant tumors was tabulated (Figure 5). Over time, the number of malignant tumor surgery ("cancer surgery") receipts showed a decreasing trend for both men and women in the pediatric and AYA groups, a decreasing trend for men in the adult group, and a slight increasing trend for both men and women in the elderly group. Unlike the oncology drug volume and other factors, there was a temporary drop in the number of surgeries in 2020 for all groups, which was thought to be due to the COVID-19 pandemic.

Calculating the 5-year moving APC average for the number of cancer surgery receipts over the 5-year moving period from 2015 to 2022, the number of boys and girls in the pediatric group was -4.5% and -2.3%, respectively. The ratio of "implantable catheter for continuous infusion of anti-cancer drugs into arteries, veins, or abdominal cavity" for local or continuous administration of tumor drugs ("anti-cancer drug catheterization") to total cancer surgeries will reach about 90% in FY2022 for both men and women in the pediatric group, and about 90% in the five-year moving average of APCs. The average 5-year mobile APCs were 10.7% and 6.9% for males and females, respectively, indicating a high rate of increase. It was confirmed that anticancer drug administration catheter placement surgery has become a mainstay in surgical treatment for pediatric cancer.

The 5-year moving APC average of the number of receipts in the AYA group was -3.5% for men and -2.2% for women. 16.8% of men and 12.2% of women underwent catheterization for anticancer agent administration in FY2022, and the 5-year moving APC average was 5.9% for men and 3.9% for women, showing the same high rate of increase as in the pediatric group.

The 5-year moving APC average for the number of receipts in the adult group was -2.1% for males and 0.6% for females.The percentage of anticancer catheter placement in FY2022 was 14.5% and 12.6% for males and females, respectively, with a 5-year moving APC average of 3.7% and 2.6% for males and females, respectively.

The 5-year moving APC average for the number of receipts in the elderly group was 0.8% and 1.1% for men and women, respectively.The percentage of anticancer catheter placement in FY2022 was 9.8% for men and 11.4% for women, with a 5-year moving APC average of 4.9% for men and 5.1% for women, showing a high rate of increase similar to the younger group.

(5) Changes in radiotherapy

Radiation therapy mainly includes chemo-radiotherapy (CRT) for solid tumors, which is given alone or in combination with chemotherapy using oncologic drugs before or after surgery or in cases where surgery is not possible. In addition to chemotherapy, total body irradiation (TBI) is a bone marrow-destructive pretreatment to destroy tumor cells in the recipient's bone marrow at the time of hematopoietic stem cell transplantation. Figure 6 shows the number of radiotherapy receipts from FY 2015 to FY 2022 (excluding various management fees and blood irradiation of transfused blood products). Characteristically, there was a decrease over time in the AYA and adult groups.

The 5-year moving APC average of the number of radiotherapy receipts from FY 2015 to FY 2022 was calculated to be -2.2% for boys and -1.2% for girls in the pediatric group; the ratio of TBI to total radiotherapy in FY 2022 was 0.99% for boys and 0.52% for girls; the 5-year moving APC average was -4.2% for boys and -15.2% for girls. The 5-year moving APC average was -4.2% for boys and -15.2% for girls. The outcomes of pre-transplantation procedures including TBI and chemotherapy-only pre-transplantation procedures in pediatric hematopoietic stem cell transplantation are considered almost equal10), suggesting that the choice of minimally invasive chemotherapy-centered procedures, known as "mini-transplantation," is increasing.

The 5-year moving APC average of the number of receipts in the AYA group was -2.9% for men and -4.1% for women; the percentage of TBI in FY2022 was 0.37% for men and 0.08% for women; and the 5-year moving APC average was 2.0% for men and -1.7% for women.

The 5-year moving APC average for the number of adult group receipts was -3.5% for males and -1.6% for females; the FY2022 TBI rates were 0.06% and 0.02% for males and females, respectively, and the 5-year moving APC average was 2.5% for both sexes.

The 5-year moving APC average of the number of receipts for the elderly group was -1.0% and -0.4% for men and women, respectively The percentage of TBI in FY2022 was 0.005% for men and 0.007% for women, which is a very small relative volume from the overall radiation therapy, but the 5-year moving APC average was 11.8% for men and 10.1% for women However, the 5-year moving APC averaged 11.8% for men and 10.1% for women, indicating an increase over time, which may be associated with an increase in the number of blood cancers in the elderly, as shown in Figure 1.

(6) Changes in the number of hematopoietic stem cell transplants

Figure 7 shows the trend of hematopoietic stem cell transplantation ("stem cell transplantation"), which is performed for the treatment of hematologic cancers and solid tumors mainly in children, when the disease cannot be cured or controlled with chemotherapy using oncologic drugs. The Japan Hematopoietic Cell Transplant Data Center/Japan Society for Hematopoietic and Immuno-Cell Therapy (JHSCT) has published a very detailed analysis of all hematopoietic stem cell transplants in Japan using the Centralized Transplant Registry Management Program. The data are presented here by age group from the Data Center's "FY2023 National Survey Report". Because modification of the data is prohibited, the age groups were not recalculated as stipulated in this report, and the published graphs are quoted.

In FY2022, there were 1953 "autologous transplants" using stem cells from the patient's own specimen, of which peripheral blood stem cell transplantation (PBSCT) accounted for 99.8% (data omitted). Patients aged 50 years or older accounted for 75.9% of all autologous transplants (71.2% in FY2015), and 47.2% were aged 60 years or older (41.3% in FY2015). There were 2,939 "allogeneic transplants" using stem cells derived from another person, 34.7% of which were cord blood transplants. Of allogeneic transplants, 57.7% (49.4% in FY2015) were performed at age 50 or older, and 31.9% (26.1% in FY2015) at age 60 or older. As with autologous transplants, the number of allogeneic transplants performed at older ages increased. The report stated, "The number of transplants performed in older age groups is increasing due to the expansion of the age range for transplantation with the spread of mini-transplants.

(7) Changes in oncology palliative and supportive care drugs

Various symptoms associated with cancer progression (concomitant symptoms) and adverse events associated with cancer treatment sometimes affect the prognosis of patients, so it is important to control these symptoms in parallel with cancer treatment. Figure 8 shows the transition in the number of units of opioids mainly used for cancer pain as drugs used to relieve cancer-related symptoms, and Figure 9 shows the transition in the number of units of G-CSF preparations prescribed for bone marrow suppression caused by oncology drugs as supportive therapy for cancer treatment.

The opioids mainly prescribed for cancer pain included oral morphine, oxycodone, hydromorphone, tapentadol, methadone, orally absorbed fentanyl, transdermal fentanyl for topical use, and suppository morphine ⁽¹¹⁾. Each injectable opioid, as well as codeine, tramadol, and buprenorphine, which are classified as weak opioids, were excluded from the tally because they have many uses other than cancer pain treatment. Significant decreases in opioid unit volume were seen in the pediatric group (5-year mobile APC average: boys -28.2%, girls -13.6%) and the AYA group (5-year mobile APC average: males -4.9%, females -5.3%). In the adult group, the rate of change was small for both men and women (5-year moving APC mean: -0.6% for men and 0.7% for women), while the elderly group showed an increase for both men and women, with a particularly high increase for women (5-year moving APC mean: 1.4% for men and 3.3% for women). The percentage of topical opioids remained unchanged or slightly decreased in all age groups (Figure 8).

Bone marrow suppression and associated febrile neutropenia (FN) caused by cytotoxic tumor agents are associated with intractable infections such as resistant bacterial and fungal infections, and have a significant impact on the success or failure of cancer treatment and the life expectancy of patients. The efficacy of granulocyte colony stimulating factor (G-CSF), which stimulates bone marrow stem cells and induces differentiation of immune cells, determines the success of oncology treatment, girls -0.6%), while the AYA group showed a marked increase in females (5-year moving APC average: 2.9% for males and 5.7% for females). The adult group also showed a similar increase in females (5-year mobile APC mean: 0.3% males and 4.0% females), while the elderly group was comparable in both genders (5-year mobile APC mean: 1.8% males and 2.5% females). The proportion of patients who have received PEGylated G-CSF has increased over the years, especially among female patients.

Summary and Discussion

Cancer treatment has advanced as a multidisciplinary treatment of medical technology. Based on surgical therapy, drug therapy, and radiation therapy, physicians have made efforts to combine these cancer treatment techniques and provide optimal medical care to patients as team medicine utilizing each specialty. Medical technologies have become more sophisticated and individualized with scientific advances, and have achieved prolongation of overall survival and progression-free survival in many types of cancer. In order to deepen our understanding of the evolution of medical technology and its contribution to patients, this paper attempts to provide an overview and quantitative analysis of the overall picture of cancer care from various open data sources, including the NDB. The following is a discussion of our analysis by age group.

(1) Pediatric group

Because detection of genetic abnormalities is the key to confirming the diagnosis of suspected hereditary tumors in pediatric cancer, the percentage of genetic testing in cancer diagnostic testing is higher than in other age groups. In 2019, the "cancer genome profiling test (cancer gene panel test)" for comprehensive detection of genetic abnormalities will be covered by insurance, further increasing the proportion of genetic testing. 2015-2022, in particular, a marked decrease in mortality rates of hematologic cancers was observed, indicating that the mortality rate of hematologic cancers has decreased significantly in addition to conventional treatments such as chemotherapy and transplantation. The marked decrease in mortality rates, especially for hematologic cancers, from 2015 to 2022 was attributed to the progress of "personalized medicine," in which the results of genetic tests are used to link patients to appropriate anticancer treatments, in addition to conventional treatments such as chemotherapy and transplantation. While the number of cancer surgeries decreased markedly, the percentage of catheterization for anticancer drug administration reached 90%, suggesting that the weight of drug therapy is increasing in pediatric cancer.

In this context, the present analysis shows that the percentage of pediatric patients using new drugs and biopharmaceuticals is increasing, but in relative terms is extremely low compared to other age groups. The increased incidence and mortality rates of solid tumors in girls have been shown, and measures to provide them with opportunities to select new oncology drugs are required. 2023 "The 12th Expert Committee on the Future of Cancer Research of the Ministry of Health, Labor and Welfare" ⁽ Ref. ¹²⁾ states that "Even if there are drugs that match the genetic abnormalities as a result of cancer gene panel tests, the use of such drugs in pediatric patients is still very low compared to other age groups. (2) There are few clinical trials in which pediatric cancer patients can participate, and (3) It is difficult to use the current patient-directed therapy because pediatric doses have not been determined. In order to solve these issues, the National Cancer Center started a "patient-directed therapy for multiple molecular-targeted therapies based on gene panel test results" trial in 2024 as a physician-initiated clinical research, mainly targeting "pediatric and AYA cancer patients aged 0-29 years who have no standard treatment or are refractory to standard treatments" (13). The study was initiated as an investigator-initiated clinical ^research13). Patients who meet the research criteria will be provided with treatment using five pediatric unapproved anticancer drugs provided free of charge by pharmaceutical companies, and this clinical research is expected to improve drug access for pediatric and AYA patients. However, the scope of the study is limited to a specific facility, with a limited supply of drugs and a limited number of patients. To improve access for pediatric patients, further cooperation among industry, government, and academia is expected so that the NHI drug price reform in FY2024, ¹⁴⁾ a policy to promote the development of pediatric indications for new drugs, and the "Pharmaceutical Affairs Consultation Center Project for Drugs for Children and Orphan Diseases" promoted by the PMDA, ¹⁵⁾ will be effective.

(2) AYA group

In the AYA group, the APC of solid cancer incidence rates for both men and women showed a 2.6% decrease, and the 5-year moving APC average of mortality rates from 2015 to 2022 showed a decrease of about 4% for men and about 6% for women in blood cancers, and about 3% for both men and women in solid cancers. Looking at changes in cancer medical technology during this period, there was no significant change in the amount of oncology drugs prescribed, while the number of receipts for cancer surgery and radiation therapy showed a downward trend for both men and women. The AYA group, as well as the pediatric group, showed a similar trend toward multidisciplinary treatment (discussed below in the adult group) with new oncology drugs and medical technologies for surgery and radiation, as well as a decrease in the number of receipts for cancer surgery and radiation therapy for both men and women. testing results may have contributed to the improved survival outcomes in the AYA group. Considering the onset of cancer pain as a surrogate outcome for cancer progression, the fact that the amount of opioids for cancer pain treatment decreased over time in the AYA group suggests that the spread of new medical technology may have contributed to the suppression of cancer progression and metastasis in the AYA group, and further detailed analysis is expected.

(3) Adult group

Cancer incidence APCs in the adult group showed a decrease of about 4% for men and about 2% for women in solid cancers, and a decrease of 1-2% for men and women in hematologic cancers; the 5-year moving APC average for cancer mortality from 2015 to 2022 was about 4% for both men and women in hematologic cancers and about 4% for men and less than 2% for women in solid cancers. Looking at changes in medical technology during this period, there was no significant change in the number of cancer-specific test receipts, but an increase in the proportion of genetic tests, and a significant increase in the total number of units of oncologic drugs for women, and an increase in the proportion of new drugs for both men and women. In the number of cancer surgery receipts, there was a downward trend for men, while the percentage of catheterization for anticancer drug administration increased for both men and women. In recent years, evidence of neoadjuvant/adjuvant therapy (preoperative/postoperative adjuvant therapy) using novel oncologic agents such as kinase inhibitors, HER2 antibodies, and immune checkpoint inhibitors has increased, and the number of radiotherapy receipts has decreased, but the percentage of patients receiving chemoradiation and immunotherapy in perioperative period of non-small cell lung cancer has increased. The number of radiotherapy receipts is decreasing, but the efficacy of multidisciplinary treatment combining chemoradiotherapy and immune checkpoint inhibitors in the perioperative period of non-small cell lung cancer has been ^{demonstrated16)}, suggesting that clinical application of new medical technologies is progressing. Although a decrease in cancer mortality has been demonstrated, no change in the use of opioids for cancer pain treatment was observed, and medical technology for adult group patients still remains a challenge in terms of controlling cancer progression and metastasis, which are the main causes of cancer pain.

(4) Elderly group

In terms of cancer incidence in the elderly group, a decrease of around 1.5% for men and women was observed in solid cancers, while an increase of about 1% for men and women was observed in hematologic cancers. The 5-year moving APC average of cancer mortality rates showed a slight decrease in men for solid cancers and an increase of about 1% in both men and women for hematologic cancers. Thus, the results showed an increase in the incidence and mortality of blood cancers in the elderly, which may be a sign of the increase in the number of hematopoietic stem cell transplants in the elderly as indicated by the Japanese Society for Hematopoietic and Immunocytological Therapy. The use of oncology drugs, the percentage of new drugs, the percentage of bio-oncology drugs, and the percentage of genetic testing showed increases over time for both men and women. The number of cancer surgery receipts did not change significantly for either sex, but as in the other age groups, the percentage of catheter placement procedures increased. Opioid use increased in both men and women, suggesting that even with the widespread use of new cancer treatment technologies, there remain high barriers to curing pain symptoms in older cancer patients.

(5) All age groups

Despite the shift from cytotoxic tumor drugs to newer tumor drugs such as kinase inhibitors and antibody drugs, there was no decrease in the use of G-CSF products in any of the patient groups aged 15 years or older, and increases were observed in some groups. In other words, neutropenia remains an important side effect of current cancer treatment that must be controlled. Neutropenia and associated refractory infections caused by resistant bacteria and fungi are serious secondary complications that can occur in the treatment of cancer patients, and control of refractory infections is essential for successful cancer treatment. Despite the increasing availability of newer oncologic agents with reduced bone marrow effects, the key drugs for solid tumors are still traditionally prescribed cytotoxic oncologic agents such as platinum-based drugs, taxanes, antimetabolites, topoisomerase I inhibitors, and antibiotics. Novel oncology drugs have evolved combination regimens with these key drugs in clinical trials. In order to control neutropenia and other systemic side effects, the development of new modalities that act locally in the tumor and inhibit cancer growth, such as ADCs, will be an important issue in oncology drug discovery in the future.

Conclusion

The accumulation of medical and other information on individual citizens, including diseases they have suffered from, medical techniques they have received, test data, care status, and outcomes, is considered a valuable social resource for the future. The analysis of medical big data is expected to be utilized for efficient and effective selection of medical technologies and research and development of medical technologies for the future, thereby contributing significantly to the advancement of medical ^care17). In April of this year, the revised Next Generation Medical Infrastructure Law went into effect, creating an environment that allows the secondary use of pseudonym-processed medical information for research and development in the health and medical fields, in addition to conventional medical information, including NDB. When death information is linked to NDB this year, ¹⁸⁾ it has been verified that the percentage of death information linked to receipts in all death information has improved to 93.9%, ¹⁹⁾ which seems to bring us one step closer to the analysis of medical technology and outcomes. However, there is still a long way to go before medical technology evaluation linked to patient outcomes can be implemented. As shown in this paper, medical technologies for "cancer" are more diverse and multidisciplinary than those for other diseases. The current open databases do not allow for an analysis that can evaluate how individual medical technologies affect outcomes. Parameters that strongly influence patient outcomes, such as disease severity/stage, comorbidities, laboratory values, and performance status, need to be incorporated into the analysis from the patient's medical record. Furthermore, genomic information identifying genetic abnormalities is expected to be linked to the database. In order for the accumulated large-scale medical data to be returned as a benefit to patients and the public as a whole, we expect the government to quickly construct a system for "linking diverse information" and "standardizing information" through ICT technological innovation so that it can bring precision to medical technology evaluation and lead to the development of next-generation medical technology.

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